Rademikibart Add-on Treatment of an Acute COPD Exacerbation (Seabreeze STAT COPD)

April 23, 2026 updated by: Connect Biopharm LLC

A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation

This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute COPD exacerbation with type 2 inflammation in the urgent healthcare setting to compare rademikibart plus standard therapy to standard therapy (plus placebo).

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Santa Fe, Argentina, S3000
        • Recruiting
        • Centro de Diagnostivo y Rehabilitación S.A. - CEDIR
        • Contact:
          • Radha Adivikolanu
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1199
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Radha Adivikolanu
      • Florida, Buenos Aires, Argentina, B1602
        • Recruiting
        • CEMER - Centro Medico de Enfermedades Respiratorias
        • Contact:
          • Radha Adivikolanu
      • Mar del Plata, Buenos Aires, Argentina, B7600FYK
        • Recruiting
        • Centro de Investigaciones Médicas Mar del Plata
        • Contact:
          • Radha Adivikolanu
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • Instituto Ave Pulmo-Fundacion Enfisema
        • Contact:
          • Radha Adivikolanu
      • Pilar, Buenos Aires, Argentina, 1629
        • Recruiting
        • Hospital Universitario Austral
        • Contact:
          • Radha Adivikolanu
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000
        • Not yet recruiting
        • Centro Medico Ipam S.A
        • Contact:
          • Radha Adivikolanu
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Recruiting
        • Investigaciones en Patologías Respiratorias SRL
        • Contact:
          • Radha Adivikolanu
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Recruiting
        • The Canberra Hospital
        • Contact:
          • Radha Adivikolanu
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St. Vincent's Hospital Sydney
        • Contact:
          • Radha Adivikolanu
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
          • Radha Adivikolanu
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • Recruiting
        • Sunshine Coast University Hospital
        • Contact:
          • Radha Adivikolanu
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • Institute for Respiratory Health
        • Contact:
          • Radha Adivikolanu
  • Georgia
      • Tbilisi, Georgia, 0159
        • Recruiting
        • LLC Diacor
        • Contact:
          • Radha Adivikolanu
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Caucasus Medical Center
        • Contact:
          • Radha Adivikolanu
      • Tbilisi, Georgia, 0112
        • Recruiting
        • LLC "Israel-Georgian Medical Research Clinic Healthycore"
        • Contact:
          • Radha Adivikolanu
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Acad. Chapidze Emergency Cardiology Center LLC
        • Contact:
          • Radha Adivikolanu
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Acad. G. Chapidze Emergency Cardiology Center
        • Contact:
          • Radha Adivikolanu
      • Tbilisi, Georgia, 0101
        • Recruiting
        • JSC "National Center for Lung Health"
        • Contact:
          • Radha Adivikolanu
  • Serbia
      • Belgrade, Serbia, 11040
        • Recruiting
        • Clinical Hospital Center "Dragisa Misovic - Dedinje"
        • Contact:
          • Radha Adivikolanu
      • Kamenitz, Serbia, 21204
        • Recruiting
        • Institute for pulmonary diseases of Vojvodina
        • Contact:
          • Radha Adivikolanu
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac
        • Contact:
          • Radha Adivikolanu
      • Niš, Serbia, 18108
        • Recruiting
        • Institute for Pulmonary Diseases and Tuberculosis Nis
        • Contact:
          • Radha Adivikolanu
      • Užice, Serbia, 31000
        • Recruiting
        • Health Center Uzice
        • Contact:
          • Radha Adivikolanu
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • Queen Elizabeth Hospital Birmingham
        • Contact:
          • Radha Adivikolanu
      • Birmingham, United Kingdom, B9 5SS
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust Birmingham Heartlands Hospital
        • Contact:
          • Radha Adivikolanu
      • London, United Kingdom, SE1 7EH
        • Recruiting
        • Guy's and St Thomas NHS Foundation Trust
        • Contact:
          • Radha Adivikolanu
      • Salford, United Kingdom, M6 8HD
        • Recruiting
        • Salford Royal Hospital - Northern Care Alliance NHS Foundation Trust Barnes Clinical Research Facility
        • Contact:
          • Radha Adivikolanu
    • Greater Manchester
      • Wythenshawe, Greater Manchester, United Kingdom, M23 9QZ
        • Recruiting
        • Medicines Evaluation Unit Ltd.
        • Contact:
          • Radha Adivikolanu
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham Lung Health Center
        • Contact:
          • Radha Adivikolanu
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Leland Stanford Junior University, Stanford Hospital
        • Contact:
          • Radha Adivikolanu
      • Valencia, California, United States, 91355
        • Recruiting
        • Amicis Research Center
        • Contact:
          • Radha Adivikolanu
    • Colorado
      • Denver, Colorado, United States, 80206
        • Recruiting
        • National Jewish Health
        • Contact:
          • Radha Adivikolanu
    • Florida
      • Bradenton, Florida, United States, 34209
        • Withdrawn
        • Synergy Healthcare
      • Miami, Florida, United States, 33125
        • Recruiting
        • Columbus Clinical Services, LLC
        • Contact:
          • Radha Adivikolanu, MD
      • Miami, Florida, United States, 33175
        • Recruiting
        • Pharmax Research of South Florida, Inc.
        • Contact:
          • Radha Adivikolanu
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Health Synergy Clinical Research, LLC
        • Contact:
          • Radha Adivikolanu
    • Georgia
      • Fayetteville, Georgia, United States, 30214
        • Recruiting
        • Primeway Clinical Research Group
        • Contact:
          • Radha Adivikolanu
      • Stonecrest, Georgia, United States, 30038
        • Recruiting
        • Pivotal Research Solutions
        • Contact:
          • Radha Adivikolanu
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
          • Radha Adivikolanu
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
          • Radha Adivikolanu
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Recruiting
        • Ochsner Medical Complex - The Grove
        • Contact:
          • Radha Adivikolanu
    • New York
      • Stony Brook, New York, United States, 11733
        • Recruiting
        • Stony Brook University Hospital
        • Contact:
          • Radha Adivikolanu
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke Asthma, Allergy, and Airway Center
        • Contact:
          • Radha Adivikolanu
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical CEnter
        • Contact:
          • Radha Adivikolanu
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Clinical Research of Rock Hill
        • Contact:
          • Radha Adivikolanu
    • Texas
      • Baytown, Texas, United States, 77521
        • Recruiting
        • Inquest Clinical Research
        • Contact:
          • Radha Adivikolanu
      • Denison, Texas, United States, 75020
        • Recruiting
        • Premier Pulmonary Critical Care and Sleep Medicine
        • Contact:
          • Radha Adivikolanu
      • McAllen, Texas, United States, 78503
        • Recruiting
        • DCT- McAllen Primary Care Research, LLC dba Discovery Clinical Trials
    • Vermont
      • Colchester, Vermont, United States, 05446
        • Not yet recruiting
        • Vermont Lung Center
        • Contact:
          • Radha Adivikolanu
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Medical Center / Carilion Roanoke Memorial Hospital
        • Contact:
          • Radha Adivikolanu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Physician-diagnosed COPD with duration of ≥12 months.
  • Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
  • Participants in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
  • Current or former smoker with a history of smoking of ≥10 pack-years.
  • Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.
  • Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation.
  • Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.

Exclusion Criteria:

  • Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
  • Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.
  • Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.
  • Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.
  • Transient ischemic attack or stroke <6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event <6 months from Screening Visit.
  • Known or suspected history of immunosuppression.
  • History of known immunodeficiency disorder or hepatitis B or C.
  • History of alcohol abuse and/or drug abuse.
  • Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success.
  • Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for >15 hours a day.
  • Participants on long-term macrolide.
  • Current acute COPD exacerbation for which SoC was started >48 hours prior to Screening.
  • A recent chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan).
  • Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization.
  • Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.
  • Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
  • Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.
  • Treatment with oral corticosteroids and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.

The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Matching placebo in prefilled syringe
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Experimental: Rademikibart
Combination product: Rademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Other Names:
  • CBP-201

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure rate
Time Frame: 28 days
Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of new moderate and severe COPD exacerbations over the 28 days after randomization
Time Frame: 28 days
28 days
Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization
Time Frame: 28 days
28 days
Mean change from baseline (CFB) in EXACT-PRO score
Time Frame: Week 1, Week 2, and Week 4
Mean CFB in clinical respiratory symptoms of COPD using the E-RS: COPD (Evaluating Respiratory Symptoms in COPD) comprised in the EXACT-PRO through Week 1, Week 2, and Week 4. The Exacerbations of Chronic Pulmonary Disease Tool - Patient-Reported Outcome (EXACT-PRO) is a PRO instrument designed to capture information on the occurrence, frequency, severity, and duration of exacerbations of disease in patients with COPD.
Week 1, Week 2, and Week 4
Absolute CFB in post-BD FEV1 at Day 3, Week 1, and Week 4
Time Frame: Day 3, Week 1, and Week 4
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Day 3, Week 1, and Week 4
Day 3, Week 1, and Week 4
Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported
Time Frame: 56 days
56 days
Incidence of unanticipated adverse device effects (UADEs)
Time Frame: 56 days
56 days
Incidence of injection site reactions
Time Frame: 56 days
56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Connect Biopharm LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBP-201-207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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